Purpose:
This is an 11-month contract position. Work a 4 shift pattern role.
Responsibilities:
• Technical knowledge of sterile manufacturing processes.
• Perform timely reviews of batch documentation/investigations/reports highlighting and assisting in the resolution of concerns commensurate with the risk.
• Respond quickly to unplanned events and technical issues.
• Operational experience with quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES.
• Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US, and EU regulatory requirements.
• Conduct, report, and display of Quality right the first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance.
• Support the spot check/walk-through process of the production lines.
• Involved in customer complaint investigation if required.
• Support the annual product quality reviews if required.
• Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
• Understanding sterile manufacturing operations is preferred.
• Ability to learn and utilize computerized systems for the daily performance of tasks.
• Ability to prioritize, manage multiple tasks, and meet deadlines.
• Perform timely reviews on batch documentation ( EBR’s ) / line clearances/ assist in the resolution of concerns commensurate with the other Department representatives to promote improvements in GMP and Quality standards.
• Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities.
• Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.
• Foster a culture of continuous improvement by deploying company Six Sigma tools and supporting the implementation of Model Area within operations from the start.
Minimum Qualifications and Experience:
• Degree qualification or equivalent (Science, Engineering, Technical.)
• Experience in Sterile Manufacturing.
• Sterile filling processes and equipment and support services experience.
• Lean Six Sigma Methodology experience desired.
• Good organizational skills and attention to detail.
• Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact cross-functionally.
• Ability to learn and utilize computerized systems for the daily performance of tasks.
• Strong influencing skills.
• Demonstrable analytical and systematic problem-solving skills.
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Apply For This JobTo apply for this job email your details to rachael.kennedy@theaphexgroup.com.
To apply for this job email your details to rachael.kennedy@theaphexgroup.com.